MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PATIENT MONITOR

Model Number M8007A

Device Problem No Display/Image (1183)

Patient Problem No Code Available (3191)

Event Date 05/29/2020

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer called philips to report that, on (b)(6) 2020 between 7am and 8am, the mp70 monitor¿s screen went blank for approximately five seconds on two to three occurrences during a surgical procedure.The customer has reported a deterioration of the patient¿s condition during the surgical procedure, requiring a transfer to the icu.The nature of the patient¿s deteriorated condition remains unknown to philips at this time, and the customer has reported that the patient remains admitted to the hospital.

Manufacturer Narrative

H3 and h6: philips field service engineer (fse) visited the customer site on 11jun2020 to evaluate the monitor.The fse determined form the customer that the monitor did not lose its configurations during the reported outages.The fse also ran operational and performance tests for two hours without finding any issues.The philips field service engineer (fse) found no trouble with the monitor.Although philips found no trouble with the device, philips cannot rule out a product malfunction.The mp70 was not connected to a central monitoring system, so alarm audit logs are unavailable.The mp70 has also been returned to service following the fse's operational and performance testing.Despite good faith effort attempts in order to obtain additional information regarding the reported deterioration and outcome of the patient, as well as any other information surrounding the event, the customer has not provided philips with any further information.No further investigation is required.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

Updated h3 and h5: submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: MP70 INTELLIVUE PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 10145657
• MDR Text Key: 194875719
• Report Number: 9610816-2020-00192
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M8007A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1